STATEMENT OF INTEREST OF AMICUS CURIAE
The Biotechnology Innovation Organization (“BIO”) is the largest trade
association representing biotechnology companies, academic institutions,
biotechnology centers, and related organizations across the United States and in more than 30 countries. Many of BIO’s members are small companies at the forefront of medical innovation.
BIO’s members have great interest in this case and the standards applied
under the Patent Act to determine whether a court should invalidate duly-issued U.S. patent claims as obvious. BIO’s members expand the boundaries of science daily through their research and development of biomedicine, diagnostics, agricultural, and environmental products and services. That research and development is possible because of investment based on the Patent Act’s promise of exclusionary rights in validly patented subject matter. That investment results in innovative products that are used to improve the quality of life for millions of
people worldwide. But if investors fear that courts are not reviewing obviousness consistently or that marketable biotechnology patents will be prone to later invalidation, future innovation will suffer from less investment. BIO’s members, therefore, seek consistency and clarity in the application of the law of obviousness to enhance predictability under the Patent Act.
BIO has no direct stake in this appeal and takes no position on the validity of the patents at issue. No counsel for a party authored this brief in whole or in part, and no such counsel or party, nor any person other than the amicus or its counsel, made a monetary contribution intended to fund the preparation or submission of this brief. This brief is solely the work of BIO; it reflects the consensus view of BIO’s members, but not necessarily the views of any individual member. BIO
certifies that all parties to this appeal have consented to BIO’s filing of this brief.
INTRODUCTION
The Supreme Court’s decision in Graham v. John Deere Co. of Kansas City,
383 U.S. 1, 17-18 (1966) identified four factors that collectively inform whether a claim would have been obvious. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Under Graham, evidence relating to each factor must be considered before a court renders its ultimate legal conclusion. Since that decision, however, this Court has developed two distinct approaches to the role played by the fourth Graham factor (objective indicia) in relation to the other three. In many cases, all
four factors are weighed together in totality, and the burden of persuasion never shifts from the defendant. However the panel in this case affirmed the “prima facie” framework, where a determination of obviousness is reached based on the first three factors and the fourth is then weighed in rebuttal.
Panels of this Court have raised concerns about inconsistences between the two approaches, but no panel has successfully reconciled them. See, e.g., In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1076 (Fed. Cir. 2012) (collecting cases); Intercontinental Great Brands LLC v. Kellogg N. Am. Co., 869 F.3d 1336, 1345-46 (Fed. Cir. 2017). The continued use of two, inconsistent approaches has created uncertainty in the law and controversy in the lower courts. En banc action is necessary to reconcile this Court’s two frameworks into a single, unified approach that gives appropriate weight to all relevant evidence before reaching a legal conclusion on obviousness. While the need for en banc action is great, the task for the Court is minimal. This is not a controversial situation—the Court need not create new law. Everyone agrees that objective evidence must be considered before reaching a final legal conclusion on obviousness. Thus, the Court need only endorse a framework and clarify its application.
“Know what you own, and know why you own it”
-P.L.
